Starting the Study

Abstract

There are multiple steps in getting off to a good start in a research trial. The first is the site initiation (SIV) visit performed by the sponsor to review the study procedures. The team members should have already read the protocol, consent, and prescreening form. Then, immediately before the first subject is enrolled, the team should have a mock subject drill. After enrolling the first subject, a Study Update Meeting should be scheduled to debrief the initiation steps of the study completed so far. Finally, it is important to insist on having the first monitor visit early so that misunderstandings can be corrected.